Table 3.
Risk of bias assessment for included clinical trials
| Author, Year | Sequence generation | Allocation concealment |
Blinding | Incomplete adverse event data |
Selective adverse event reporting |
Other |
|---|---|---|---|---|---|---|
| Bashey 2009 | High | N/A | High | Low | Low | Low |
| Borghaei 2015 | Low | N/A | High | Low | Low | Low |
| Brahmer 2010 | High | N/A | High | Low | High | High |
| Brahmer 2012 | High | N/A | High | Low | Low | Low |
| Brahmer 2015 | Low | Low | High | Low | High | Low |
| Calabro 2014 | N/A | N/A | High | Low | Low | High |
| Downey 2007 | High | N/A | High | Low | Low | High |
| Gibney 2014 | High | N/A | High | Low | Low | High |
| Hersh 2014 | Low | Unclear | High | Low | High | Low |
| Hodi 2014 (1) Cancer Immunol Res |
High | N/A | High | Low | Low | High |
| Hodi 2014 (2) JAMA | Low | Low | High | Low | High | Low |
| Kwon 2014 | Low | Low | Low | Low | Low | Low |
| Larkin 2015 | Low | Low | Low | Low | High | Low |
| Le 2013 | Low | Unclear | High | Low | Low | High |
| Lynch 2012 | Unclear | Unclear | Low | Low | Low | Low |
| Merchant 2015 | High | N/A | High | Low | High | High |
| Motzer 2015 | Unclear | Unclear | Low | Low | Low | Low |
| Postow 2015 | Low | Low | Low | Low | Low | Low |
| Prieto 2012 | High | N/A | High | Low | High | High |
| Ralph 2010 | N/A | N/A | High | Low | Unclear | High |
| Reck 2013 | Unclear | Unclear | Low | Low | High | Low |
| Ribas 2015 | Low | Low | Low | Low | High | Low |
| Rizvi 2015 | N/A | N/A | High | Low | High | High |
| Robert 2011 | Low | Low | Low | Low | High | Low |
| Robert 2014 | Low | Low | High | Low | High | Low |
| Robert 2015 (1) NEJM Nivo |
Low | Low | Low | Low | Low | Low |
| Robert 2015 (2) NEJM Pembro |
Low | Low | Low | Low | Low | Low |
| Sangro 2013 | N/A | N/A | High | Low | Unclear | High |
| Sarnaik 2010 | High | N/A | High | Low | Low | Low |
| Weber 2008 | High | N/A | High | Low | High | Low |
| Weber 2015 | Low | Low | High | Low | High | Low |
| Yamazaki 2015 | N/A | N/A | High | Low | Low | High |
| Yang 2007 | High | N/A | High | Low | High | High |
Nivo: Nivolumab. Pembro: Pembrolizumab.
N/A: not applicable (i.e. allocation concealment is not applicable for trials with no randomization, sequence generation is not applicable in single arm trials with only one dosing regimen). Selective adverse event includes not reporting all grades of events or not reporting all types of events on which information was collected. Other sources of bias: small size of study, stopped early, ascertainment of IRAE changed during the study.